FDA Accepts Braeburn ' s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

Prescription Drug User Fee Act (PDUFA) action date set for May 23, 2023. Plymouth Meeting, Pa.—December 8, 2022—Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly...
Source: Drugs.com - New Drug Applications - Category: Drugs & Pharmacology Source Type: news